It has long been said that a national reporting standard is needed to ensure all American women receive at least the same basic information regarding breast density, and a spotlight put on the importance of routine breast imaging. This month, our One on One … column features leading breast cancer specialist Wendie Berg, MD, PhD, FACR, FSBI, who shares information on what is being done in the fight against breast cancer. The full video interview with her can be found here.
ITN: How was the FDA’s recent implementation of a national standard for breast density notification an important step forward for women’s health?
BERG: I think most women are well aware that breast screening with mammography reduces their chances of dying from breast cancer, but it has not been nearly as well known that mammography does not benefit all women and does not benefit everybody equally.
We've known for many years now that at least 40% of women have dense breasts. Dense breasts can hide cancer, and they also increase the risk of developing breast cancer, but that information was not being provided to women. Mammography misses at least 40% of cancers in the densest breasts, extremely dense breasts, misses about 25% of cancers and heterogeneously dense breasts. And so starting in 2009, the first state law requiring that women be told something about breast density was passed in Connecticut through the efforts of Nancy Capello and soon after in New York through the efforts of JoAnn Pushkin, another patient advocate who's been very active with DenseBreast-info.org with me. And now currently there are 38 state laws that require some form of density notification, and about 90% of American women are covered by those laws. The problem is even with a law, the information that a woman receives has been variable. For example, even in Connecticut, a woman was not actually told if she herself has dense breasts, at least not by law. Many facilities would do it, but it wasn't clear in the language of the law. And so now effective with the final rule for the mammography Quality Standards Act that the FDA just issued in September of 2024, all facilities in the United States will be required to provide consistent information to women. Their lay letter with the results from the mammogram will have to state either they have not yet the breasts are not dense or their breasts are dense. It will also have to state that dense tissue is a risk factor for developing breast cancer and cancers can be hidden on the mammogram can be masked because of the dense tissue. If a woman has dense breasts, that letter will also have to state that other tests besides mammography may help find additional cancers. So at least we now will soon have a uniform consistent standard for all women.
I think now the challenge of course will be how to implement that in practice so that women realize the potential benefit from this information. We obviously are not doing this to confuse people or to cause stress, we're doing this because there is the potential to have additional screening. I had done of course lots of studies with ultrasound with the Acrin 6666 trial, in which MRI was much better than ultrasound. Most insurance will cover screening ultrasound for women with dense breasts, but it's mostly subjected to a copay or deductible. MRI is of course indicated for many women who are at higher risk. But implementing that in practice has been a challenge for facilities to identify who are the high risk women based on family history risk models; it's not so straightforward. At least now women who are aware of the issue of their dense tissue, they know the mammogram is more limited. They at least can discuss the potential for adding ultrasound screen or an MRI screen with their doctor and especially I would encourage them to talk to the radiologist, and for radiologists to be more actively involved in these discussions educating the referring physician community and their patients, and making clear recommendations.
Going forward one of the barriers, as I mentioned, is insurance. And there are a variety of state laws right now. Fifteen states plus the District of Columbia have some form of insurance law that requires insurance to cover supplemental screening but only in New York, Illinois and Connecticut is that without a copay or deductible. And so there's still an out-of-pocket cost that can be rather substantial, especially for an MRI. And of course there are access issues for getting an MRI even if your doctor will write the order for it. You can't always get it or can't always get it promptly. And of course, abbreviated MRI, the quicker shorter tests that can be done at lower cost. That's something that has been a challenge to implement as well because there hasn't been a specific billing code for that CPT code. There now about 200 facilities in United States that do offer abbreviated MRI one way or another. Many of them charged directly to the patient anywhere from $200-600. So, a woman could get it but she would have to be willing to pay out of pocket. There is a website that lists all the facilities that currently offer it, or many of the facilities that offer it which is timetobeseen.org but it's not available in every state and it's certainly not available in every location.
ITN: How should this new FDA ruling be addressed with patients?
BERG: It's very important with the final rule that the language that is specified by the FDA on their website is used verbatim without any edits in the letter to the patient. We can add as a facility, for example, if the state law requires that we provide the specific density category, fatty, scattered, heterogeneously dense or extremely dense, the FDA language, but we cannot alter the language that is specified by the FDA in the final rule. And I think there may be some points of confusion. For example, if the state law says breast density can hide cancers and the FDA law says that dense tissue makes it harder to find breast cancer, there are little differences in the language. It may be a little bit challenging to reconcile these differences and the FDA encourages facilities to call their hotline or email them with questions if they're not sure what to do, and I'm hoping individual states will provide some guidance on this. I know the state of Maryland law, by definition, defaults to the federal standard once there's a federal standard, so that was good foresight on the part of those in Maryland. But that's the only state where that is true. And then the other issue I wanted to mention is that for the FDA to come to this point was quite a long process. The first committee hearing about making a national standard was actually in 2011 and JoAnn Pushkin, Executive Director of DenseBreast-info.org (DBI), was one of a handful of patient advocates, and there were a few physicians also there who met and presented the rationale for this to the FDA, and they agreed that this was a good idea in 2011. But it was only through the persistent efforts of Joanne and also Senator Dianne Feinstein and ultimately, Representative Rosa DeLauro from Connecticut, that the FDA actually came through with this language, now, the final rule. They were required to issue this standard and 2019 but then things were on hold for a while with the pandemic, and we are so glad to see this national standard finally come out.
ITN: You recently received funding for critical research on breast cancer from the Breast Cancer Research Foundation. Tell us how you are working to improve breast cancer detection in women who have a history of breast cancer or dense breast tissue — which mammography doesn’t adequately detect?
BERG: In addition to women with dense breasts, there are also other women for whom mammographic screening is not really enough. And we've known again for many years that women who have a personal history of breast cancer really are at high risk for having a second cancer down the road. And many of those cancers are not seen on the mammogram, sometimes because of scar tissue or sometimes because they're more subtle. There are various reasons, but we have reduced performance with a mammogram in that population. So I've been looking at ways to improve cancer screening for women with a personal history of breast cancer for many years. They were included in the Acrin 6666 trial of ultrasound and MRI. And now we're looking at contrast enhanced mammography as an alternative.
I mentioned that not everyone can access an MRI and I think contrast enhanced mammography has the potential to be implemented much more broadly, because with a relatively minor upgrade to equipment, it can actually be performed on most mammogram units that are out there and certainly mammogram units are widespread, much more available than MRI equipment. It is still challenging, of course, because it requires injecting iodinated contrast, which means starting an IV, and a woman can't have an allergic history with contrast. It's the same contrast that's used for CT scanning. Makes you feel warm over for a minute or two. It's a very strange feeling and then it goes away quickly. So there is a little more to it than just having a standard mammogram. But the results that we're getting are very encouraging.
And I'd actually done a separate study with funding from the Pennsylvania Breast Cancer Coalition of Women who meet Pennsylvania law criteria for supplemental screening because of dense breasts, or also family history or other risk factors such as the prior a typical biopsy like lobular carcinoma in situ. And we're getting very similar results with contrast enhanced mammograms in both that population and in women with personal history. We are finding very early cancers, very small, mostly invasive, but also ductal carcinoma in situ that is missed sometimes, especially if it doesn’t have calcifications. We can find that. And the results are very encouraging with at least sort of 30% of the findings that we think are suspicious turned out to be cancer. Cancer detection rates on the order of 10 per 1,000, which is comparable to what we see with MRI screening in the same populations. So it seems to be a very nice alternative if a woman can tolerate it.
And right now the biggest barriers are training staff to start IVs and billing issues again, because it's currently only FDA approved for diagnostic use. And so to implement it for screening facilities are usually doing it as a diagnostic mammogram and billing for the contrast in administration. But it's not quite straightforward for just flipping a switch and making this happen nationally. The Contrast-Enhanced Mammography Imaging Screening Trial (CMIST) that Dr. Christopher Comstock and others will be leading soon, I think it's just opened with funding from the Breast Cancer Research Foundation and GE Healthcare. They will be further validating, of course, the use of contrast mammography for screening, and I think that may help with FDA and billing, and obviously when we start publishing our results as well soon, that should also help with moving things forward.
ITN: Comparing contrast-enhanced mammography to 3D mammography for better screenings has been a major focus for you. What can you tell us about this technology? Does it have the potential to soon become the new standard?
BERG: Again, the technology does require an intravenous line to be started. We often have to check kidney function before we inject it to contrast if there's any history of high blood pressure, or diabetes or other factors that might affect the kidneys. We then inject the contrast which takes about a minute and then wait about two minutes, and then we do the breast imaging which is, from a patient's perspective, almost identical to a standard mammogram. It's the same positioning.
We take two exposures: one low energy that looks like a standard mammogram, and one higher energy. Only the iodine absorbs the higher energy, and then the computer can show us by subtracting one from the other and with a little extra processing it can show us just what's enhancing. And we see the cancers, of course, because they have more vessels, leaky vessels, and will show up right against a basically gray or dark gray background. And it's again much more effective at finding cancers and is very similar to MRI and its performance. We are finding many, many cancers that we did not see on standard mammogram or a 3-D tomosynthesis mammogram. I think most of the studies other than ours compared it only to standard 2-D, and we have been comparing it to the 3-D tomosynthesis and finding a much greater cancer detection rate with the contrast mammogram.
The total exam only takes about 10 minutes, and then the interpretation is pretty easy because we really only have the standard views with the contrast to look at when we're interpreting the contrast mammogram. It's pretty easily trained, and we actually published our results on training radiologists, how to do it and how to interpret it. There is standard terminology now from the American College of Radiology BI-RADS to use to describe the findings. And as I mentioned, the outcomes are very good.
So at this point, the biggest barrier to widespread implementation is the issue of practicalities of billing and practicalities of staffing, training and contrast reactions. And, of course at times over the last few years with all of the supply chain issues, there have been occasional shortages of biogenetic contrast and tubing, and other things that have plagued many issues in medicine in general. But again, this can be done at low cost. I don't think the contrast is very inexpensive, and it's not difficult to upgrade equipment to allow for this technology. It did take a while for the breast imaging community to recognize that while we had MRI, we knew it wasn't going to be something we could do in everybody.
One of the things that we found in the Acrin trial and very similar results in the dense study in the Netherlands, that slightly over 40% of women did not want an MRI even at no cost, the biggest issue being claustrophobia. You do have to lie in a tunnel for an MRI and that's just not tolerated that well by a lot of women. Contrast mammography of course is done like a regular mammogram. So from a positioning standpoint, there's no tunnel. It's just the compression. If you don't like having your breast squeezed then you might like an MRI better, but we still of course generally do a mammogram as well as an MRI, even when we're doing MRI screening.
The contrast mammogram has the potential to be done all in one visit. You can get all the information that you need, and it can be very efficient. In many cases, we're able to directly schedule a patient for biopsy because we know there's a suspicious finding that needs to be biopsied and fairly recently, many facilities now have direct contrast-enhanced mammogram guided biopsy, which again is an important step. If you're going to use any technology, you need to be able to biopsy suspicious findings using that technique directly. You can't depend on being able to find it with ultrasound targeted to that area. And of course, you don't want to have to require the patient have an MRI to find something that you found on the contrast mammogram to do the biopsy because she may not be able to tolerate an MRI. So it has been an important step in moving the technology forward for wider adoption as well.
ITN: What still needs to be done in the fight against breast cancer, and reinforcing the importance of early detection?
BERG: So I think two big things. The first is the insurance issues that we mentioned for supplemental screening. If we really want to realize the benefits that the FDA even mentions in their final rule, they say the reason we're doing this is because this should improve early cancer detection, reduce the cost of treatment, reduce the morbidity of treatment and improve women's health. If we're going to realize that women have to know about it, they have to be able to act on it and have information to decide if they want to have additional screening. But as I mentioned, insurance is the biggest barrier for that. So, we need a standard across the board so that no matter where a woman lives, she can access that. There is something called the Find it Early Act that Representative Congresswoman Rosa DeLauro from Connecticut and Representative Brian Fitzpatrick from Pennsylvania, introduced at the end of the last congressional session and they're planning to reintroduce it within the next two months. That would require a national standard with no copay or deductible across the board for all women to have access to appropriate breast screening, including diagnostic imaging. If we find something that's abnormal, that additional testing would also be covered up to the need for biopsy, at which point insurance would need to cover that. But I think that is a huge step. It's a huge need. And we do have information about that act and how to contact your congresspeople and support that on the DenseBreast-info.org website on the legislation tab. I would encourage everyone to follow up on that as it gets introduced.
I think the other big piece, as I sort of alluded to, is education. We really need the patients to know they're going to get the information now that their breasts are dense and they're going to get information if they have dense breasts that they may benefit from supplemental screening, or that there are tests that may find more cancers. But we need to let them know what those tests are, and maybe that this is the test that we offer at our facility, that we would suggest you have. We also need to educate the referring physician community because several studies that we've done through DenseBreast-info.org have shown there is a huge gap in referring provider knowledge about density and what to do about it.
I think the biggest misunderstanding that we discovered was actually that they thought that tomosynthesis or 3-D mammograms were enough, and solve everything. Well, it doesn't. It's a little bit better than a standard mammogram. It finds maybe one or two more cancers per 1,000. We find five or so with a standard mammogram, and we find six or seven with tomosynthesis. But there are another seven to 10 to find every year that we're not seeing on the mammogram if we do contrast enhanced MRI or mammography. So, that is what we need to communicate, and they need to understand these tests, and if a patient asks for it or is interested in pursuing additional screening, the referring doctor needs to help with that by writing the order. The facility can do more to make it easier to order standing orders in Epic, or drop down menus that say you know this patient has dense breasts. She wants to have additional screening something that makes it easy to implement, and hopefully in the near future. We will have easier ways to identify women who have other risks as well, and put all that information together to really make very clear recommendations. These patients should have an MRI.
We have a paper that's about to come out in the Journal of Breast Imaging that will detail with existing guidelines women who have extremely dense breasts and also have some family history, for example, or women who have heterogeneously dense breasts, prior biopsy and some family history. They already meet high risk criteria to get an MRI with current national guidelines, but we're not generally doing that. So, what we need is to make those practices clear, make the explanations clearer, make the recommendations clear in our reports in our communications and help educate women on these issues. DenseBreast-info.org is designed to provide information to patients and referring healthcare providers as well. We have a chart that compares how many cancers you find with each technology; and how many false positive recalls for things that are not cancer are caused by each technology. It is the information that a woman and her doctor need to help make these decisions about extra screening. But there are plenty of other ways to implement things as well.
Women need to know that dense breasts are normal. You can't tell by the way the breast looks or feels. It's something we see on the mammogram and your breasts will either be called dense which means they're heterogeneously dense or extremely dense in the language in the report or not dense fatty or scattered. And this information can help a woman decide whether or not she wants to have extra screening. And it's time for us to implement the extra screening that we already have validated and make this available to women and make them aware of this option.
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April 18, 2024 
